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Trial record 5 of 178 for:    Enzalutamide

Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by University of Colorado, Denver
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02953860
First received: November 1, 2016
Last updated: March 23, 2017
Last verified: March 2017
  Purpose
A phase 2 study to evaluate the tolerability and clinical activity of adding enzalutamide to fulvestrant treatment in women with advanced breast cancer that are ER and/or PR positive and Her2 normal.

Condition Intervention Phase
Breast Cancer
Drug: Fulvestrant with Enzalutamide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Trial of Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Clinical benefit rate of the combination of enzalutamide/ fulvestrant [ Time Frame: 24 Weeks ]
    To determine the clinical benefit rate (complete and partial response plus stable disease for 24 weeks) of the combination of enzalutamide/fulvestrant.


Secondary Outcome Measures:
  • Androgen receptor (AR) expression in breast tissue in the tumor biopsies of each patient [ Time Frame: 24 Weeks ]
    Patient biopsies will be obtained pretreatment, during treatment, and at the time of tumor progression to determine the AR expression and signaling in the breast tissue. The degree of AR expression in the nucleus will be reported by immunohistochemistry (IHC) strength of staining (0-3+) and % nuclei stained and the relationship between tumor response and degree of AR expression and/or AR signaling will be examined

  • Progression-free survival (PFS) [ Time Frame: 24 Weeks ]
    PFS is defined as the time from the first day of enzalutamide treatment (Study Day 1) until documented disease progression or death on study, whichever occurs first.

  • Overall response rate [ Time Frame: 24 Weeks ]
    Tumor response will be assessed using RECIST 1.1

  • AR signaling in breast cancer tissue in the tumor biopsies [ Time Frame: 24 weeks ]
    To obtain serial biopsies of breast cancer pretreatment, during treatment and at time of tumor progression in order to determine the extent of AR expression and signaling in breast tissue, to evaluate the effect of enzalutamide on the tumor, and to evaluate the relationship of these effects on clinical outcomes.


Estimated Enrollment: 24
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fulvestrant with Enzalutamide
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.
Drug: Fulvestrant with Enzalutamide
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
Other Names:
  • FASLODEX
  • MDV3100

Detailed Description:
This is a single arm, non-randomized, open-label phase 2 study designed to evaluate the tolerability and clinical activity of adding enzalutamide to fulvestrant treatment in women with advanced breast cancer that are ER and/or PR-positive and Her2 normal. In this study 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be, in conjunction with Fulvestrant, PO daily.
  Eligibility

Ages Eligible for Study:   18 Years to 101 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ER+ Her2- breast cancer
  • Metastatic
  • At least 18 years of age
  • Candidate for fulvestrant therapy - patients who have started fulvestrant may enter this trial if within 3 months of starting fulvestrant
  • Measurable or Evaluable by RECIST 1.1
  • PS 0-2
  • Able to swallow study drug and comply with study requirements
  • Tumor available for fresh biopsy (two biopsies - pretreatment as regards enzalutamide, and during treatment @4 weeks). (The patient will be asked if they would be willing to provide a third biopsy at time of progression)
  • Patients may already have gotten the loading doses of fulvestrant and/or ovarian suppression
  • If patient is pre- or peri- menopausal, then will need to have concurrent ovarian suppression.
  • ANC >1000/uL, platelets >75,000/uL at screening visit
  • Total bilirubin < 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert's disease)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN or < 5 times ULN if patient has documented liver metastases
  • Creatinine < 1.5 times ULN
  • INR < 1.5 times ULN, or if on warfarin, can safely transition off for biopsy
  • Willing to donate blood for research at 4 time points
  • Written informed consent obtained prior to biopsies and blood samples

Exclusion Criteria:

  • Current or previously treated brain or leptomeningeal metastases
  • History of seizures
  • Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464).
  • Systemic estrogens or androgens within 14 days before initiating therapy. Vaginal estrogens are allowed if necessary for patient comfort.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02953860

Contacts
Contact: Tiffany Colvin 720-848-0664 TIFFANY.COLVIN@UCDENVER.EDU

Locations
United States, Colorado
University of Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Tiffany Colvin    303-848-0664    TIFFANY.COLVIN@UCDENVER.EDU   
Principal Investigator: Anthony D Elias, MD         
Sponsors and Collaborators
University of Colorado, Denver
United States Department of Defense
Investigators
Principal Investigator: Anthony D Elias, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02953860     History of Changes
Other Study ID Numbers: 16-1001.cc
Study First Received: November 1, 2016
Last Updated: March 23, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Advanced Breast Cancer
ER+/Her2 Advanced Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones

ClinicalTrials.gov processed this record on May 25, 2017